Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

BRIEF SUMMARY INFO MUST BE INCLUDED IN Rx AD EVEN IF PRDDUCT NAME NOT MENTIONED

Executive Summary

BRIEF SUMMARY INFO MUST BE INCLUDED IN Rx AD EVEN IF PRDDUCT NAME NOT MENTIONED when the ad states that the product "is an effective treatment for a specific disease," FDA is informing industry in a statement, entitled "Clarification of FDA Policy on 'Institutional,' 'Corporate' or 'Health Message Advertising Practices." The agency asserts: "There appears to be a belief that omitting a specific drug name from an advertisement or other descriptive matter makes that material an 'institutional' or 'corporate' message and an exemption is provided from the requirements of the ]FD&C[ Act; it provides no such exemption." FDA points out that "some 'institutional' or 'corporate' advertisements may become promotional through undue emphasis, direct or indirect, on a product (or products of the type) manufactured by the sponsor, and subject to drug advertising requirements." FDA told "The Pink Sheet" that it reexamined its policy on Rx consumer advertising in light of, among other things, a recent television campaign by Hoechst-Roussel that addressed intermittent claudication but did not mention Hoechst-Roussel's Trental by name. The firm has received a reg letter from FDA. The agency explained that its policy has been to allow advertising that promotes public awareness: of companies as corporate entities; of the areas of research and development firms are involved in; of diseases companies have been instrumental in curing or ameliorating; and "in publicizing the signs and symptoms of diseases for which effective treatment (including in some cases non-drug therapy) are available." FDA said "the message relating to the specific diseases generally recommend to the reader that they see their physician for treatment of the condition discussed but they avoid reference to specific products manufactured by the sponsoring firm."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

OM013164

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel